Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001258741
Ethics application status
Approved
Date submitted
13/11/2013
Date registered
18/11/2013
Date last updated
18/11/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy and safety of artemether-lumefantrine for the treatment of uncomplicated falciparum malaria in the provinces of Zivie/Atlantic, Kouande/Atacora and Zakpota /Zou in the Republic of Benin
Scientific title
Therapeutic efficacy and safety study of fixed combination of artemether-lumefantrine for the treatment of children with uncomplicated falciparum malaria in the provinces of Zivie/Atlantic, Kouande/Atacora and Zakpota /Zou in the Republic of Benin
Secondary ID [1] 283580 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Uncomplicated falciparum malaria 290483 0
Condition category
Condition code
Infection 290875 290875 0 0
Other infectious diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is a an open label single arm surveillance study to confirm the efficacy and safety of the first-line antimalarial treatment, artemether-lumefantrine, for the treatment of uncomplicated falciparum malaria in children aged between 6 months a 12 years. All eligible patients will be enrolled on day 0 and received artemether-lumefantrine as fixed-combination tablet (20 mg artemether and 120 mg lumefantrine) twice daily for 3 consecutive days. The number of tablets to be administered for each dose ( morning and evening) is based on body weight according to standard treatment (5-14 kg, 1 tb; 15-24 kg, 2 tb; 25-34 kg, 3 tb; over 35 kg 4 tb). Each dose will be administered under the supervision of a qualified study staff member. Clinical and parasitological examinations will be conducted at each of the scheduled follow-up visit on days 1,2,3,7,14,21, and 28 or any other day if symptoms re-occurred.
Intervention code [1] 288269 0
Not applicable
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290869 0
Proportion of patients with adequate clinical and parasitological response adjusted by PCR (polymerase chain reaction)
Timepoint [1] 290869 0
Day 28
Secondary outcome [1] 305507 0
Incidence and nature of adverse events. Possible adverse events are those known to occur with antimalarials and include, headache, body ache, nausea, vomiting, abdominal discomfort, liver enzyme elelevation, and dizziness
Timepoint [1] 305507 0
Day 28
Secondary outcome [2] 305512 0
Hematocrit
Timepoint [2] 305512 0
Baseline and Day 28
Secondary outcome [3] 305513 0
In vitro susceptibility testing of Plasmodium isolates to artemether-lumefantrine
Timepoint [3] 305513 0
Day 0

Eligibility
Key inclusion criteria
Age between 6 months and 12 years
Minimum body weight of 5kg
Mono-infection with plasmodium falciparum confirmed by microscopy
Parasitemia between 1000-200000 asexual forms parasites per microliter
Axillary temperature equal or greater than 37.5 degrees Celsius or history of fever in the past 24 hours
Able to swallow oral medication
Capable and willing to follow protocol requirement, including schedule of assessments
Written consent from parent/guardian
Minimum age
6 Months
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Presence of signs in children aged under 5 years, or signs of severe falciparum malaria according to WHO definition
Mixed or mono infection with another Plasmodium species detected by microscopy
Presence of severe malnutrition (defined as a child whose growth standard is below minus 3z score, has symmetrical oedema involving at least the feet, or has mid-upper arm circumference less than 110 mm
Presence of febrile conditions due to diseases other than malaria (measles, acute lower respiratory tract infection, severe diarrhea with dehydration), or other known underlying chronic diseases (cardiac, renal and hepatic diseases, HIV/AIDS)
Regular medications, which may interfere with the antimalarial pharmacokinetics
History of hypersensitivity reaction or contraindications to any of the medicine(s) being tested or used as alternative treatments

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
22/11/2013
Actual
Date of last participant enrolment
Anticipated
31/01/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
180
Accrual to date
Final
Recruitment outside Australia
Country [1] 5619 0
Benin
State/province [1] 5619 0
Zinvie/Altlantic
Country [2] 5620 0
Benin
State/province [2] 5620 0
Kouande/Atacora
Country [3] 5621 0
Benin
State/province [3] 5621 0
Zakpota/Zou

Funding & Sponsors
Funding source category [1] 288265 0
Government body
Name [1] 288265 0
Ministere de la Sante Benin
Programme National de Lutte contre le Paludisme (PNLP)
Country [1] 288265 0
Benin
Funding source category [2] 288266 0
Other
Name [2] 288266 0
World Health Organization
Country [2] 288266 0
Switzerland
Primary sponsor type
Government body
Name
Ministere de la Sante Benin
Address
01 BP882
Cotonou
Country
Benin
Secondary sponsor category [1] 286982 0
None
Name [1] 286982 0
Address [1] 286982 0
Country [1] 286982 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290164 0
World Health Organisation Ethics Review Committee
Ethics committee address [1] 290164 0
20 Avenue Appia
CH1211 Geneva 27
Ethics committee country [1] 290164 0
Switzerland
Date submitted for ethics approval [1] 290164 0
Approval date [1] 290164 0
08/11/2013
Ethics approval number [1] 290164 0
RPC597

Summary
Brief summary
This is an open label prospective surveillance study to confirm the efficacy and safety of artemether-lumefantrine for the treatment of uncomplicated falciaprum malaria in children from 6 months to 12 years of age in three provinces of Benin.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 44262 0
Dr Yves Eric Donan Denon
Address 44262 0
Programme National de Lutte contre le Paludisme (PNLP)
01 BP 6974
Cotonou
Country 44262 0
Benin
Phone 44262 0
+229 2133930
Fax 44262 0
Email 44262 0
[email protected]
Contact person for public queries
Name 44263 0
Yves Eric Donan Denon
Address 44263 0
Programme National de lutte contre le Paludisme (PNLP)
01 BP 6974
Cotonou
Country 44263 0
Benin
Phone 44263 0
+229 2133930
Fax 44263 0
Email 44263 0
[email protected]
Contact person for scientific queries
Name 44264 0
Yves Eric Donan Denon
Address 44264 0
Programme National de lutte contre le Paludisme (PNLP)
01 BP 6974
Cotonou
Country 44264 0
Benin
Phone 44264 0
+229 2133930
Fax 44264 0
Email 44264 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.